Advancing Drug Development for Respiratory Syncytial Virus

Speakers

Michael Boeckh, MD, PhD,
Jason Chien, MD, MSc
Gregory Daniel, PhD, MPH
Selena Daniels, PharmD
Filip Dubovsky, MD, MPH
H. Cody Meissner, MD
Mark McClellan, MD, PhD
Flor M. Munoz, MD, MSc
Jeffrey S. Murray, MD, MPH
Barbara A. Rath, MD, PhD
Jeff Roberts, MD
Alan Murray Shapiro, MD, PhD, FAAP
Prabha Viswanathan, MD
Edward Walsh, MD
Robert C. Welliver, Sr, MD

Description

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and children around the world, resulting in three million hospitalizations and several hundred thousand deaths annually, the vast majority of which occur in developing nations. Treatment options for RSV are limited, and efforts to produce a vaccine have been unsuccessful thus far. Given the burden of disease and the morbidity linked to severe RSV-associated LRTIs, there is a need for new therapeutic agents to treat RSV infections. Improvements in scientific understanding of the disease as well as advances in key technologies have recently spurred a range of new development activities around RSV therapeutics. However, progress has been slowed by numerous challenges, including difficulties in clinical trial design and a lack of scientific consensus on robust and reliable clinical endpoints.

In light of these ongoing issues, and under a cooperative agreement with the U.S. Food and Drug Administration (FDA), the Duke-Margolis Center for Health Policy held an expert workshop on May 2nd titled, “Advancing Drug Development for Respiratory Syncytial Virus.” This workshop provided an opportunity for pharmaceutical manufacturers, academics, and other stakeholders to discuss solutions to clinical and regulatory barriers to the development of RSV therapeutics.

Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.